Dilation devices and methods for removing tissue specimens

ABSTRACT

The invention provides devices and methods for use in removing tissue samples from within a patient&#39;s body. The devices include instruments having shafts for cutting a path to a tissue mass, and an inflatable balloon or balloons attached to the shaft effective to dilate the path upon inflation in order to aid in the removal of tissue masses from within the body of a patient. The devices also include instruments having dilation plates that may be inserted into a path leading to a tissue mass to be removed, and the plates separated effective to dilate the path to aid in the removal of tissue masses. Methods include inserting a device into a path leading to a tissue mass, and inflating a balloon or separating plates, thereby widening the path, and removing the tissue mass. Such devices and methods find use, for example, in biopsy and in lumpectomy procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present invention is a continuation-in-part of U.S. patentapplications Ser. No. 09/057,303 for “Breast Biopsy System and Method,”filed on Apr. 8, 1998, Ser. No. 09/146,185 for “Methods and Apparatusfor Securing Medical Instruments to Desired Locations in a patient'sBody,” filed on Sep. 1, 1998, Ser. No. 09/159,467 for “ElectrosurgicalBiopsy Device and Method,” filed on Sep. 23, 1998, Ser. No. 09/238,965“Tissue Specimen Destruction Device and Method Thereof,” filed on Jan.27, 1999, Ser. No. 09/356,187 for “Electrosurgical Lesion LocationDevice,” filed on Jul. 16, 1999, and Ser. No. 09/477,255 for “Apparatusand Method for Accessing a Biopsy Site,” filed on Jan. 4, 2000, allassigned to the assignee of the subject application, which are eachhereby incorporated by reference in their entirety, and from each ofwhich priority is claimed under 35 U.S.C. 120.

FIELD OF INVENTION

This invention relates generally to medical devices, particularlydevices for removing tissue specimens from within a patient's body, suchas biopsy devices, and methods for using such devices.

BACKGROUND OF THE INVENTION

In diagnosing and treating certain medical conditions, such aspotentially cancerous tumors, it is often medically desirable to removea tissue mass. For example, during a biopsy a specimen of suspicioustissue may be removed for pathological examination and analysis, and ina lumpectomy a suspicious mass is removed from a patient's breast topreclude spread of malignant tissue. Tissue that is removed during abiopsy, lumpectomy, or other procedure may include all or part of theidentified tissue mass, and may also include a surrounding margin ofhealthy tissue. In order to minimize bleeding, trauma to the patient,and for cosmetic reasons, the path through which the biopsy instrumentpasses into a patient's body is preferably a small one. However, inorder to collect enough tissue to allow for a proper diagnosis, or toinsure that no malignant tissue remains within a patient's body, it isoften desirable to remove a mass of tissue that is wider than the entrypath. In many cases removal of this large tissue mass requires furthertrauma to the patient, including cutting or tearing the skin and tissueof the patient in order to enlarge the exit path for removal of thetissue.

Accordingly, devices and methods for removing a tissue specimen withoutcutting or causing unnecessary additional trauma to the patient aredesired.

SUMMARY OF THE INVENTION

This invention is directed to a tissue removing device, such as a biopsydevice, and method of use thereof and, more specifically, a device forthe relatively non-traumatic removal of a tissue mass through a tissuepassageway leading to the tissue mass which has smaller transversedimensions than the tissue mass.

The tissue removal device embodying features of the invention generallyhas an elongated shaft with a distal region for securing the tissue massto be removed and a tissue expander proximal to the tissue securingregion to expand the tissue passageway to facilitate the tissue massremoval.

The tissue expander surrounding the shaft may take a variety of forms.For example, the expander may be in the form of an inflatable balloonsecured to the shaft and having an interior in fluid communication witha passageway in the elongated shaft to deliver inflation fluid to theballoon. Other forms include dilation plates which deploy radially awayfrom a shaft, elongated members which expand arcuately away from a shaftor which expand spirally away from a shaft, and a meshwork which expandsradially away from a shaft.

The invention provides devices and methods for use in removing tissuesamples and suspect tissue masses from within a patient's body whileminimizing trauma to the patient. The devices and methods of theinvention expand and widen the entry path leading to the tissue to beremoved, thereby aiding in its removal form the patient's body. Suchexpansion or widening of the entry path, also termed dilation, isaccomplished by devices that exert outward pressure on the walls of thetissue path. In one embodiment, devices having a balloon or balloonsdilate the tissue path with balloon inflation. In another embodiment,arms inserted into the path, which may have end plates or otherspecialized shapes configured to engage tissue, exert outward pressureon the walls of the tissue path by outward movement of the arms so thatthe arms and end plates press outwardly on the path to widen it.

In an embodiment, the invention provides an intracorporeal device havingan elongate shaft with a cutting surface attached to a distal portion ofthe shaft, and an inflatable balloon attached to the elongate shaft. Inembodiments of the invention, the inflatable balloon is attached to theshaft proximal of the distal end of the shaft. In further embodiments,the device has a plurality of inflatable balloons attached to the shaft.In embodiments of the invention, the plurality of balloons includes adistal balloon attached to a distal portion of the elongate shaft, and aproximal balloon attached to the elongate shaft proximal of the distalballoon.

The devices of the invention may include a cutting surface or aplurality of cutting surfaces. For example, a device embodying featuresof the invention may have a cutting surface attached to its distal end.A device with a plurality of cutting surfaces may have a cutting surfaceattached to its distal end and another cutting surface attached to theelongate shaft proximal of the distal end. Thus, intracorporeal deviceshaving a single cutting surface or a plurality of cutting surfaces mayinclude a balloon or a plurality of balloons, where the balloons includea distal balloon attached to a distal portion of the elongate shaft, anda proximal balloon attached proximally of the distal balloon. Devicesembodying features of the invention may also include an anchoringdevice, which may include at least one extendable element configured todeploy from a retracted position adjacent the elongate shaft to anextended position.

In yet further embodiments, the invention provides an intracorporealdevice including an elongate shaft with a plurality of cutting surfaces,including a distal cutting surface attached to the distal end and a sidecutting surface extendably and retractably attached to the elongateshaft proximal of said distal end; and having a balloon or a pluralityof balloons attached to the elongate shaft. The plurality of balloonsmay include a distal balloon attached to a distal portion of theelongate shaft, and a proximal balloon attached to the elongate shaftproximal of the distal balloon. The side cutting surface may be attachedto the elongate shaft between proximal and distal balloons. The devicemay further have an anchoring device, which may include at least oneextendable element configured to deploy from retracted position adjacentsaid elongate shaft to an extended position. The anchoring device may beattached to the elongated shaft between a distal balloon and a proximalballoon.

The invention also provides methods for removing a tissue specimen froma tissue bed within a patient's body with a device having a balloon orballoons. The methods include positioning a device embodying features ofthe invention along a path in a tissue bed within a patient's body;inflating a balloon effective to dilate the path; and removing thetissue specimen. The methods of the invention may further includeanchoring the tissue specimen to said intracorporeal device. Accordingto the methods of the invention, a balloon, or a plurality of balloons,including, e.g., a proximal balloon and a distal balloon, may beinflated to aid in the removal of the tissue specimen. In embodiments,inflation of a proximal balloon is effective to dilate a path leading toa tissue mass within a patient's body. In other embodiments, inflationof a distal balloon is effective to aid in the removal of a tissuespecimen from a tissue bed.

Devices embodying features of the invention may have means other thanballoons for dilating a path leading to a tissue mass within a patient.In yet further embodiments, the invention provides a dilation device fordilating a path within a patient's body, including a proximal handleportion; a distal dilation portion having an expandable transversedimension and at least one inner surface configured to enclose at leasta portion of a shaft; and a dilation mechanism effective to enlarge thetransverse dimension of the dilation portion. In embodiments, thedilation portion includes at least two arms each having distal ends withouter surfaces, the outer surfaces being configured to engage tissue.The dilation mechanism may include a pivot configured to separate thearms. In further embodiments, the handle portion may include a pair oflegs operably connected to the pivot and arms effective that motion ofthe legs together is effective to separate the two arms.

In further embodiments, the invention provides a method for dilating apath within a patient's body, where the path contains an elongated shaftat least partly therethrough, including the steps of enclosing at leasta portion of the elongated shaft with at least a distal dilation portionof a dilation device having an expandable transverse dimension, at leastone inner surface configured to enclose at least a portion of anelongated shaft, and at least one outer surface configured to engagetissue; and enlarging the transverse dimension of said dilation portioneffective to dilate a path through the tissue bed. The distal dilationportion may include at least two arms each having distal ends with outersurfaces, the outer surfaces being configured to engage tissue, furthercomprising a step of separating the at least two distal ends effectiveto engage tissue within said tissue bed; the methods may further includesteps of compressing the handle portion effective to separate said atleast two distal ends, and where the dilation mechanism includes apivot, the compression of the handle portion is effective to rotate saidat least two arms about said pivot effective to separate the arms. Thehandle portion may be a single handle connected to both legs of thedevice, or may be separate handle portions for each leg.

The devices and methods of the invention are useful for enlarging anexit path for removal of tissue samples from within a patient's body. Insome embodiments, the devices include balloons, and in otherembodiments, the devices include mechanical devices including a pivot.The balloon and mechanical devices and methods may be used individually,or may be used together, to provide the advantage of enabling theremoval of tissue samples without need for cutting or tearing the skin,or for creating large entry wounds to remove tissue. Thus, the devicesand methods of the invention minimize trauma to a patient during biopsy,lumpectomy, or other such procedures, and reduce resulting physical andcosmetic damage to the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a device embodying features of theinvention having a balloon, showing the balloon in a deflatedconfiguration.

FIG. 1B is a perspective view of a device embodying features of theinvention having a balloon, showing the balloon in an inflatedconfiguration.

FIG. 1C is a cross-sectional view of the device of FIG. 1B taken alongline 1C-1C.

FIG. 1D is a cross-sectional view of the device of FIG. 1B taken alongline 1D-1D.

FIG. 2A is a perspective view of a device embodying features of theinvention having two balloons, showing the balloons in a deflatedconfiguration.

FIG. 2B is a perspective view of a device embodying features of theinvention having two balloons, showing the proximal balloon in aninflated configuration and the distal balloon in a deflatedconfiguration.

FIG. 2C is a perspective view of a device embodying features of theinvention having two balloons, showing the balloons in inflatedconfigurations.

FIG. 2D is a cross-sectional view of the device of FIG. 2C taken alongline 2D-2D.

FIG. 2E is a cross-sectional view of the device of FIG. 2C taken alongline 2E-2E.

FIG. 2F is a cross-sectional view of the device of FIG. 2C taken alongline 2F-2F.

FIG. 2G is a cross-sectional view of the device of FIG. 2C taken alongline 2G-2G.

FIG. 3A is a perspective view of a device embodying features of theinvention having a balloon in a deflated configuration, anchored inplace in a breast shown in phantom.

FIG. 3B is a perspective view of the device of FIG. 3A with a balloon inan inflated configuration, during removal of a tissue specimen fromwithin a breast shown in phantom.

FIG. 4A is a perspective view of a device embodying features of theinvention having two balloons, shown in a deflated configuration,anchored in place in a breast shown in phantom.

FIG. 4B is a perspective view of the device of FIG. 4A with the proximalballoon in an inflated configuration and dilating a path out from withina breast shown in phantom.

FIG. 4C is a perspective view of the device of FIG. 4A with bothballoons in inflated configurations during removal of a tissue specimenfrom within a breast shown in phantom.

FIG. 5A is a perspective view of a mechanical dilating device embodyingfeatures of the invention showing the device in a closed configurationpartially enclosing the shaft of a tissue-cutting device.

FIG. 5B is a perspective view of a mechanical dilating device embodyingfeatures of the invention shown in an opened configuration around theshaft of a tissue-cutting device.

FIG. 6A is a perspective view of a mechanical device embodying featuresof the invention shown in a closed configuration shown in place around atissue-cutting device in a breast shown in phantom.

FIG. 6B is a perspective view of the device of FIG. 6A with shown in anopen configuration, during removal of a tissue specimen from within abreast shown in phantom.

FIG. 7A is a perspective view of a device embodying features of theinvention having a plurality of expandable plates, showing the plates ina partially expanded configuration.

FIG. 7B is a perspective view of the device of FIG. 7A, showing theplates in a maximally expanded configuration.

FIG. 8A is a perspective view of a device embodying features of theinvention having a plurality of radially expandable bands, showing thebands in an expanded configuration.

FIG. 8B is a perspective view of a device embodying features of theinvention having a plurality of spirally expandable bands, showing thebands in an expanded configuration.

FIG. 8C is a perspective view of a device embodying features of theinvention having an expandable meshwork, showing the meshwork in anexpanded configuration.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A and 1B show a balloon dilation device 10 including a handle 12,and an elongate shaft 14 oriented along a longitudinal axis 15 defininga distal direction away from handle 12 and a proximal direction towardshandle 12. The elongate shaft 14 has a distal portion 16 with a tip 18.A distal cutting surface 20 is shown in this embodiment to be an arcuateelectrosurgical cutter spaced distally from tip 18. Slots 22 along shaft14 house anchor elements 24 (retracted so not shown in FIG. 1A) shown inan extended configuration in FIG. 1B. Anchor elements 24 may extend fromslots 22 to anchor the device 10 to adjacent tissue. Side cuttingsurface 30, shown in FIG. 1A in an extended configuration and in FIG. 1Bin a retracted configuration, may be used to cut tissue to isolate amass of tissue from a surrounding tissue bed within a patient's body.Side cutting surface 30 may be an electrosurgical cutter as illustratedin FIGS. 1A and 1B.

Device 10 illustrated in FIG. 1A and FIG. 1B has a single balloon,proximal balloon 26, located proximal of the tip 18 along shaft 14 andshown in a deflated configuration in FIG. 1A and in an inflatedconfiguration in FIG. 1B. Proximal balloon 26 may be inflated by passageof a fluid, which may be either a gas or a liquid, along inflation tube28 into proximal balloon 26. The fluid is caused to flow into andinflate balloon 26 by pressure from an inflation mechanism 32,illustrated in FIGS. 1A and 1B as a syringe connected to the device 10by a tube.

FIG. 1B shows device 10 with proximal balloon 26 in an inflatedconfiguration. Inflation of balloon 26 while device 10 is in placewithin a path leading to a tissue specimen within a patient's bodypresses balloon 26 against body tissue, effective to compress anddisplace the body tissue and to expand the path. Tissue specimens may beremoved through the path as the device is withdrawn from the body.Fixation of the tissue mass 52 to the shaft 14 by anchor elements 24brings the tissue mass 52 out of the tissue bed 58 as the device 10 iswithdrawn from the patient's body. The expanded path makes possible theremoval of larger tissue specimens than would otherwise be possible, andeases the removal of all tissue specimens regardless of size whileminimizing trauma and damage to the patient.

Side cutting surface 30 may be extended and retracted by movement ofside-cutter deployment shaft 44 effected by side-cutter shuttle 42.Handle 12 includes within it rotary mechanism 34 effective to rotateshaft 14, and anchor element extension mechanism 36 for extending anchorelements 24 into tissue, comprising shuttles 38 visible in the viewshown in FIGS. 1A and 1B. Shuttles 38 connect with deployment shafts 40and 41 shown in FIGS. 1C and 1D. Conductor 46 provides electrical powerto distal cutting surface 20 by connecting power source 48 with distalcutting surface 20. Power source 48 may be a source of radiofrequency(RF) power.

Distal cutting surface 20 is effective to cut tissue and so to aid inthe entry of device 10 into, and the passage through, a patient's body.In preferred embodiments, distal cutting surface 20 and side cuttingsurface 30 are electrosurgical cutting elements receiving RF power frompower source 48 effective to cut tissue. In addition, cutting surfaces20 and 30 may be used to cauterize tissue when desired. Rotation ofshaft 14 while side cutting element 30 is in a deployed configuration iseffective to cut a path through surrounding tissue and to isolate atissue specimen around the shaft 14 of device 10.

In embodiments of the invention, the device 10 may have a plurality ofballoons. As illustrated in FIGS. 2A-2G, a device 10 embodying featuresof the invention has two balloons, a proximal balloon 26 and a distalballoon 50. Both balloons 26 and 50 are shown in a deflatedconfiguration in FIG. 2A; proximal balloon 26 is shown inflated, anddistal balloon 50 deflated, in FIG. 2B; and both balloons 26 and 50 areshown inflated configurations in FIG. 2C. Fluid may flow into balloonsfor inflation. Fluid flows into proximal balloon 26 via tube 28 and intodistal balloon 50 via tube 51.

The device 10 having two balloons 26 and 50 is shown in cross section inFIGS. 2D-2G. FIG. 2D is a cross-sectional view of the device of FIG. 2Ctaken along line 2D—2D, and shows the outer circumference of distalballoon 50 and elements of shaft 14, including anchor elements 24,anchor element deployment shaft 40, and distal cutting surface conductor46. FIG. 2E is a cross-sectional view of the device of FIG. 2C takenalong line 2E—2E, showing side cutting surface 30 and the region ofshaft 14 between balloons 26 and 50. FIG. 2F is a cross-sectional viewtaken along line 2F—2F showing the outer circumference of proximalballoon 26 and shaft 14 and elements in the interior of shaft 14. Across-sectional view of the device 10 proximal of balloon 26, takenalong line 2G—2G, is shown in FIG. 2G. Proximal balloon inflation tube28 and distal balloon inflation tube 51 are effective to carry fluid forinflation of proximal balloon 26 and distal balloon 50, respectively.Outflow of fluid is effective to allow balloons to deflate.

Devices and methods of the invention may be used to remove tissuespecimens from any suitable location within a patient's body. FIGS. 3Aand 3B illustrate the removal of a tissue mass 52 from within the breast54 of a patient. A device 10 having a single balloon, proximal balloon26, is shown in place in a breast 54 in FIGS. 3A and 3B. Anchor elements24 are shown anchoring the isolated tissue mass 52 to the device 10.Proximal balloon 26 is in the deflated configuration in FIG. 3A, and inan inflated configuration in FIG. 3B. Inflation of proximal balloon 26presses walls 57 of path 56 outwardly, dilating the path so it canaccommodate the passage of tissue mass 52. Path 56 crosses tissue bed 58and skin 59 and dilation of path 56 is effective to compress and stretchtissue bed 58 and skin 59 but does not tear or cause undue trauma tothese parts of the patient's body. The dilation of path 56 reduces oreliminates the need for cutting tissue bed 58 or skin 59 to remove thetissue mass 52. Removal of the tissue mass 52 anchored to the shaft 14by anchor elements 24 is accomplished by proximal movement of the device10.

In FIGS. 3A and 3B, the elongate shaft 14 of device 10 is shown insertedinto the patient with tip 18 having passed through the suspect tissuemass 52 location within a patient's body and with shaft 14 occupying aposition within a path 56 through tissue bed 58, the path 56 leading tothe tissue mass 52 that is to be removed. Distal cutting surface 20 isused to aid in making a path to the desired location within a patient'sbody and in positioning the device in a desired location. Deployment ofside cutting surface 30 and rotation of shaft 14 rotated causes sidecutting surface 30 to cut tissue effective to isolate a tissue mass 52from the surrounding tissue bed 58. Distal cutting surface 20 and sidecutting surface 30 may be provided with, e.g., RF power, and used aselectrosurgical cutting elements. Anchoring elements 24 are showndeployed from slots 20 to anchor the isolated tissue mass 52 to thedevice 10. Proximal balloon 26 is shown in its inflated configuration inFIG. 3B, effective to press on tissue and expand the diameter of thepath 56 leading to the isolated tissue mass 52. The expanded path moreeasily accommodates the removal of the isolated tissue mass 52 fromwithin the breast 54.

FIGS. 4A, 4B and 4C illustrate a device 10 having two balloons anchoredin place in a breast 54 shown in phantom, showing the balloons deflated(FIG. 4A), the proximal balloon inflated and the distal balloon deflated(FIG. 4B), and both proximal and distal balloons inflated (FIG. 4C). InFIG. 4A, the shaft 14 is shown in place within path 56 extending throughthe isolated tissue mass 52, which is anchored to the shaft 14 byanchoring elements 24. FIG. 4B illustrates the device 10 of FIG. 4A withthe inflated proximal balloon 26 shown dilating path 56 to aid theremoval of isolated tissue mass 52. FIG. 4C illustrates the device ofFIG. 4A with both balloons in the inflated configuration during removalof a tissue specimen from within a breast shown in phantom.

FIGS. 4A-4C illustrate one method of use of a device 10 having twoballoons 26 and 50. In use during a diagnostic or therapeutic procedureto remove tissue from a patient, the sequence of inflation of balloons26 and 50 would follow the sequence shown in FIGS. 2A, 2B and 2C. Thus,the elongate shaft 14 of device 10 would be inserted into the patient tobring tip 18 near to or through the desired location within a patient'sbody, with shaft 14 occupying a position within a path leading to thetissue mass that is to be removed. Distal cutting surface 20 may be usedto aid in making a path to the desired location within a patient's bodyand in positioning the device in a desired location. Side cuttingsurface 30 may be deployed and shaft 14 rotated, thereby rotating theother elements of the device, including side cutting surface 30, andcausing side cutting surface 30 to cut tissue and to isolate a tissuemass from the surrounding tissue bed. Anchoring elements 24 may bedeployed from slots 20 to anchor device 10 to the isolated tissue mass52. Proximal balloon 26 is next inflated, pressing on tissue andexpanding the diameter of the path 56. The expanded path 56 may moreeasily accommodate the removal of the isolated tissue mass 52. Distalballoon 50 is next inflated, pressing on tissue and urging the deviceand attached tissue mass out along the path 56, further aiding in theremoval of the isolated tissue mass 52. In preferred embodiments, and asillustrated in FIGS. 2A-2G, tip-cutting surface 20 and side cuttingsurface 30 may be provided with electrical power, such as RF power, andused as electrosurgical cutting elements.

The devices of the invention may also be dilation devices having pivots,with and without inflatable balloons. Examples of dilation devices 102without balloons are shown in FIGS. 5 and 6. Such mechanical devices 102may be used together with balloon dilation devices 10 to form a tissueremoval system 100. In addition, a tissue removal system 100 may includea tissue cutting device 60 and a dilation device 102. FIG. 5A is aperspective view of a dilation device 102 embodying features of theinvention showing the device in a closed configuration partiallyenclosing the shaft of a tissue-cutting device 60. The tissue cuttingdevices shown in FIGS. 5 and 6 have features described in co-pendingapplications Ser. Nos. 09/057,303; 09/146,185; 09/159,467; 09/238,965;and 09/356,187 named and incorporated supra. Thus, the tissue cuttingdevices 60 illustrated in FIGS. 5 and 6 are effective to isolate atissue mass 52 and to anchor the mass to the device 60.

As shown in the tissue removal system 100 illustrated in FIG. 5A and 5B,a dilation device 102 having features of the invention includes a pairof arm portions 104 having distal ends. 106 configured to dilate tissue.As illustrated in FIGS. 5 and 6, distal ends 106 have dilation plates108 for engaging and dilating tissue along a path within a patient'sbody. A pivot 110 joins the two arm portions 104 and joins leg portions112 effective that lateral motion of leg portions 112 moves arm portions104. As shown in FIGS. 5A, 5B, 6A, and 6B, leg and arm portions arecontinuous and shaped from a single piece of material, hinged by pivot110. However, in embodiments of the invention, arm portions 104 and legportions 112 may be formed of different pieces of material and joinedtogether during manufacture of a dilating device 102. Leg portions 112have handles 114 at their distal ends 116. The distance 120 between legportions 112 is a variable distance depending on the position of legportions 112 with respect to pivot 110. In embodiments, a single handle114 may join legs 112.

In FIG. 5A, leg portions 110 form an angle 118 with arm portions 104effective that movement of leg portions 110 towards each other (so as toreduce distance 120) causes arm portions 104 to separate. The result ofsuch movement reducing the distance 120 is shown in FIG. 5B, showingarms 104 separated. Such separation of arms 104, when dilation plates108 are in place within a path 56 within a patient's body, is effectiveto dilate a path 56 and to aid in the removal of a tissue specimen.

In a scissors, a blade portion is aligned with an axis parallel to ahandle axis so that motion around a central pivot causes congruentmotion of the blade and handle. Thus, in a scissors, separating thehandles separates the blades. Such movement, where two blades areseparated when two handle portions are open, is termed “scissor-like.”Alternatively, where a scissors has blades and handles that are notaligned, but meet at an angle so that the handle portions are separatedwhen the blade portions are together, squeezing the handle portionseparates the blades. Such an arrangement is not scissor-like.

The configuration of arm portions 104 and leg portions 112 around pivot110 in the device illustrated in FIGS. 5A and 5B, where arms 104 areanalogous to the blades of a scissors, is not scissor-like. Connectedarm portions 104 and leg portions 112 form an obtuse angle 118 aroundpivot 110, so that when arm portions 104 are in contact, leg portions112 are separated, and conversely, when leg portions 112 are closetogether or in contact, arm portions 104 are separated. An operatorholding the leg portions 112 of a dilation device 102 as illustrated inFIGS. 5A and 5B can dilate tissue in contact with dilation plates 108 bysqueezing together legs portions 112. Distance 120 is larger in FIG. 5Athan in FIG. 5B, the leg portions 112 shown in FIG. 5A are shown fartherapart than in FIG. 5B.

FIG. 6A shows a tissue removal system 100 including a dilation device102 shown with dilation plates 108 in a closed configuration in placearound a tissue-cutting device 60 within a breast. In this embodiment,the handles 114 and arms 104 are in a scissor-like configuration. Anchorelements 24 are shown anchoring tissue cutting device 60 to an isolatedtissue mass 52. Dilation plates 108 are in place within path 56 leadingto isolated tissue mass 52. The mechanical dilation device 102illustrated in FIGS. 6A and 6B differs from the dilation device 102illustrated in FIGS. 5A and 5B in the orientation of arm portions 104,pivot 110 and leg portions 112, the devices having different angles 118and behaving differently in response to reduction in distance 120between leg portions 112. Reduction in distance 120 effects separationof arm portions 104 in the device 102 illustrated in FIGS. 5A and 5B.However, the dilation device 102 illustrated in FIGS. 6A and 6B isconfigured so that increasing distance 120 between leg portions 112 iseffective to separate arm portions 104 and to press dilation plates 108into path 56 so as to press on walls 57 effective to dilate path 56 toenable the removal of isolated tissue mass 52, as shown in FIG. 6B. Thearm portions 104 and leg portions 112 are configured in a scissor-likeconfiguration around pivot 110 in the dilation device 102 illustrated inFIGS. 6A and 6B. Thus, an operator holding the dilation device 102illustrated in FIGS. 6A and 6B can dilate tissue in contact withdilation plates 108 by moving legs portions 112 apart. Distance 120 islarger in FIG. 6B than in FIG. 6A, the leg portions 112 shown in FIG. 6Bare shown farther apart than in FIG. 6A.

In embodiments of the invention, devices having other forms of tissueexpanders instead of balloons, or in addition to balloons, may be usedto dilate a path through tissue. For example, a dilation device 130embodying features of the invention may have tissue expanders in theform of dilation plates 132 configured to deploy from a retractedposition adjacent a shaft 14 to configurations, as shown in FIGS. 7A andB, that are partially expanded (FIG. 7A) and maximally expanded (asshown in FIG. 7B) as deployment struts 134 rotate around pivots 136.Deployment shuttles 138 may be connected by hollow shafts, rods, bands,or other elements housed within shaft 14 to deployment struts 134 so asto move deployment struts 134 in order to deploy and to retract dilationplates 132.

Other examples of devices with tissue expanders are shown in FIGS.8A-8C. In FIG. 8A, a device 140 with tissue expanders having a pluralityof radially expandable bands 142 is shown, with the bands in an expandedconfiguration spaced radially away from the shaft 14. The bands areeffective to contact and to dilate tissue along a tissue path when thebands 142 are deployed to assume an expanded configuration. Collars 144at the ends of the bands 142 may be moved longitudinally towards eachother to effect deployment of the bands 142, and may be movedlongitudinally away from each other to effect retraction of the bands142. Movement of expandable bands 142 may be effected by, e.g., movementof deployment shuttles 138 that are connected by hollow shafts, rods,bands, or other elements housed within shaft 14 to collars 144. In FIG.8B, a device 150 with tissue expanders is illustrated having a pluralityof spirally expandable bands 152. The spirally expandable bands 152 areshown in an expanded configuration spaced away from the shaft 14. Thespirally expandable bands 152 are effective to contact and to dilatetissue along a tissue path when the spiral bands 152 are deployed toassume an expanded configuration. The spirally expandable bands 152 maybe deployed by movement of a collar 144 or of collars 144, where suchmovement may be rotational movement around the longitudinal axis 15 ofshaft 14, longitudinal movement along the longitudinal axis 15 of shaft14, or a combination of such movements. FIG. 8C shows a device 160 withtissue expanders having an expandable meshwork 162, the meshwork 162being shown in an expanded configuration. The meshwork 162 is effectiveto contact and to dilate tissue along a tissue path when the meshwork162 is deployed to assume an expanded configuration. The meshwork 162may assume a retracted configuration adjacent shaft 14, and may bedeployed to dilate a path into an expanded configuration as shown by,e.g., longitudinal movement of collars 144 towards each other alongshaft 14.

A method for removing a tissue specimen 52 from a tissue bed 58 within apatient's body is illustrated by FIGS. 3A and 3B. Elongate shaft 14 ofdevice 10 may be inserted into the patient to bring tip 18 near to orthrough the desired location within a patient's body, with shaft 14occupying a position within a path 56 leading to the tissue mass that isto be removed. Distal cutting surface 20 may be used to aid in making apath 56 to the desired location within a patient's body and inpositioning the device in a desired location. Side cutting surface 30may be deployed and shaft 14 rotated, thereby rotating the otherelements of the device including side cutting surface 30 and causingside cutting surface 30 to cut tissue and to isolate a tissue mass 52from the surrounding tissue bed 58. Anchoring elements 24 may bedeployed from slots 22 to anchor device 10 to the isolated tissue mass52. Proximal balloon 26 may then be inflated by fluid flow throughinflation tube 28, pressing on path walls 57 and expanding the diameterof the path 56, aiding in the removal of the isolated tissue mass 52. Inpreferred embodiments, distal cutting surface 20 and/or side cuttingsurface 30 may be provided with electrical power, such as RF power, andused as electrosurgical cutting elements.

Another method for removing a tissue specimen 52 from a tissue bed 58,using a device 10 having two balloons 26 and 50, is illustrated by FIGS.4A-4C. In use during a diagnostic or therapeutic procedure to remove atissue mass 52 from a patient, the sequence of inflation of balloons 26and 50 would follow the sequence shown in FIGS. 2A, 2B and 2C. Thus,following insertion of the device 10 into the patient to bring tip 18near to or through the desired location within a patient's body, sidecutting surface 30 may be deployed and shaft 14 rotated, causing sidecutting surface 30 to cut tissue and to isolate a tissue mass from thesurrounding tissue bed. Anchoring elements 24 may be deployed from slots22 to anchor device 10 to the isolated tissue mass. Proximal balloon 26may then be inflated, pressing on path walls 57 and expanding thediameter of the path 56. The expanded path 56 may more easilyaccommodate the removal of the isolated tissue mass 52. Distal balloon50 may next be inflated by fluid flow via inflation tube 51, pressing ontissue and urging the device 10 and attached tissue mass 52 out alongthe path 56, further aiding in the removal of the isolated tissue mass52. In preferred embodiments, and as illustrated in FIGS. 2A-2G, distalcutting surface 20 and side cutting surface 30 may be provided withelectrical power, such as RF power from a RF power source 48, and usedas electrosurgical cutting elements.

In preferred embodiments, the distal cutting surface 20 and side cuttingsurface 30 are electrosurgical cutting surfaces. Power to these cuttingsurfaces may be from any suitable source of electrical power, preferablya source of RF power 48. In one embodiment of the invention, the sourceof RF power 48 can operate at frequencies from about 200 kiloHertz (kHz)to about 10 megaHertz (MHz). Preferably, side cutting electrode 30receives RF power at a frequency of, for example, between about 2.5 MHzand about 7.5 MHz, preferably at a frequency of about 5 MHz, at avoltage of between about 450V to about 550V and at a power of up toabout 400 Watts (W). In embodiments of the invention, a distal cuttingsurface receives RF power at a frequency of about 300 kHz to about 1.5MHz, preferably about 500 kHz to about 1000 kHz, more preferably about700 kHz to about 900 kHz, at a power of, for example, between about 50 Wto about 150 W, and more specifically, at a power of from about 80 W toabout 100 W. The distal cutting surface and side cutting surface arealso effective to cauterize tissue when sufficient amounts of power(typically greater than the amounts listed above) are supplied to them.Examples of suitable power sources are disclosed in co-owned, co-pendingU.S. patent application Ser. No. 09/752,978, filed Dec. 28, 2000, thedisclosure of which is hereby incorporated by reference in its entirety.

Devices 10, 130, 140, 150, 160 and devices 102 of the invention may beused together for removing a tissue specimen from a tissue bed within apatient's body. Thus, one embodiment of a method for removing a tissuespecimen includes the steps of positioning a device 10 as illustrated inFIGS. 1-4, having a shaft 14 with an inflatable balloon 26 adjacent atissue specimen 52 along a path 57 in a tissue bed 58 within a patient'sbody; enclosing a portion of the shaft 14 with a portion of a dilationdevice 102 as illustrated in FIGS. 5 and 6; inflating a balloon 26effective to dilate the path 56 through the tissue bed 58; enlarging thetransverse dimension of the dilating device 102, as by manipulating thearms 104 having dilation plates 106 to separate the legs 112 of thedilating device 102, effective to dilate a path 56 through the tissuebed 58; and removing said tissue specimen 52.

Balloons may be made from any suitable material or materials, includingpolymers, rubber (both natural and synthetic such as latex and siliconrubber). For example, balloons may be made from polymers and polymerblends, including polymers such as polyamides, polyesters, polyethylene,polyimides, polytetrafluoroethylene (Teflon®), polyurethane, polyvinylchloride, polynitrile, polyethylene terephthalate and polyolefinpolymers. Balloons may be made from flexible and foldable materials suchas woven material, braided material, knit material, web material, meshmaterial, film material, flexible laminate material; and/or elasticmaterial.

Balloons may be inflated by increasing internal pressure within theballoon, as by flow of a fluid into the balloon to fill and expand theballoon. The fluid may be a gas or liquid. In one embodiment, a balloonand balloon inflation tube is connected by a conduit to a syringe filledwith a liquid, such as water, saline, mineral oil, or othersubstantially incompressible liquid. Pressure on the plunger of thesyringe forcing the fluid out of the syringe, through the conduit, andinto the balloon is effective to inflate the balloon. The conduit may bea flexible tube, such as one made from Tygon® tubing, and may passthrough a valve or be fitted with a clip or clamp. Closure of a valve orclamp or placement of a clip onto the conduit, such as a dialysis clip,is effective to prevent fluid flow after inflation of the balloon so asto maintain the balloon in an inflated configuration as long as isdesired. Alternatively, a balloon may be connected to a source of highpressure air or gas, and may be inflated by allowing air or gas into theballoon until a desired amount of inflation and internal pressure hasbeen achieved.

Dilation devices embodying features of the invention may be made fromany suitable material, including metals, composites, plastics, andceramics. For example, devices 102 embodying features of the inventionmay be made stainless steel, which may be coated with a biocompatiblematerial, or from a biocompatible polymer, composite, such as aglass-reinforced nylon, high density polyethtlene (HDPE), or otherdurable material. Devices 10, 130, 140, 150, and 160 may similarly bemade from any suitable material, including metals, composites, plastics,ceramics, and combinations of such materials, and are typically madefrom more than a single material.

Preferably, the devices embodying features of the invention are madefrom materials that are suitable for sterilization, includingultraviolet, chemical and radiation sterilization. Such sterilizablematerials include stainless steel and other metals, ceramics,composites, plastics, and such polymers as polyethylene, polypropylene,a fluorinated ethylene polymer, or other material.

Devices embodying features of the invention may also include otheruseful features that may aid placement or removal of tissue masses fromwithin a patient. For example, markings 31, as shown in FIG. 1A, may beplaced along shaft 14 of a device 10, 130, 140, 150 or 160 to aid anoperator in determining the depth of tip 18. Other useful features maybe included in a device 10, 102, 130, 140, 150, 160, or other devicesand systems embodying features of the invention. Thus, while particularforms of the invention have been illustrated and described, it will beapparent that various modifications can be made without departing fromthe spirit and scope of the invention. Accordingly, it is not intendedthat the invention be limited, except as by the appended claims.Reference to the terms “members,” “elements,” “sections,” “expanders,”and terms of similar import in the claims which follow shall not beinterpreted to invoke the provisions of 35 U.S.C. §112(paragraph 6)unless reference is expressly made to the term “means” followed by anintended function.

1. An elongated tissue removing device, comprising: a. an elongate shaftwith a region for securing a tissue mass on a distal shaft section; andb. a tissue expander on the elongate shaft proximal to the tissuesecuring region to facilitate removal of a tissue mass. 2-44.(Cancelled)
 45. A biopsy assembly for removing a tissue specimen from atarget site within a patient's body, comprising: a. a biopsy devicehaving an elongate shaft, a tissue cutting element on a distal shaftportion configured to separate a tissue specimen from surrounding tissueat a target site and at least one specimen securing element on thedistal shaft section to secure a separated tissue specimen to theelongate shaft; and b. a tissue dilation device having a plurality ofexpanding elements which have a first contracted configuration to fitabout the elongate shaft of the biopsy device and for following apassageway within the patient's body leading from an opening in thepatient's body to the target site therein and which have a secondexpanded configuration which expands the passageway within the patient'sbody to facilitate removal of the biopsy device with the attached tissuespecimen from the patient's body through the passageway.
 46. The biopsyassembly of claim 45, wherein the tissue dilation device comprises: a) afirst expansion member having an elongated handle with an operabledistal end, a manually manipulatable proximal end, a tissue expander onthe distal end having an exterior configured to fit into the passagewayleading to the target site and a finger grip on the proximal end; b) asecond expansion member having an elongated handle with an operabledistal portion with a distal end, a tissue expander on the distal endhaving an exterior surface configured to fit into the passageway leadingto the target site and an interior surface configured to surround theelongated shaft of the biopsy device, a proximal portion with a manuallymanipulatable proximal end, and a finger grip on the proximal end; andc) a pivotal connection between the first and second expansion memberswhich facilitates adjustment of spacing between the tissue expanders onthe first and second expansion members by manipulation of the proximalends of the first and second expansion members..
 47. The biopsy assemblyof claim 46 wherein at least one of the tissue expanders of the tissuedilation device has an inner surface with a recess configured to fit onan exterior portion of the biopsy device.
 48. The biopsy assembly ofclaim 46 wherein at least one of the tissue expanders of the tissuedilation device has a distally tapered exterior surface whichfacilitates advancement of the tissue expander within the passagewayleading to the target site.
 49. The biopsy assembly of claim 46 whereinthe tissue expanders of the tissue dilation device are at an angle withrespect to the distal portion of the handle to facilitate advancement ofthe tissue expanders without interference with a portion of the biopsydevice extending out of the passageway.
 50. A biopsy assembly forseparating a tissue specimen from a target site within a patient's bodyand removing the separated specimen from the patient's body, comprising:a. a biopsy component having an elongate shaft, a tissue cutting elementon a distal shaft portion configured to separate a tissue specimen fromsurrounding tissue at a target site and at least one specimen securingelement on the distal shaft section to secure a separated tissuespecimen to the elongate shaft; and b. a tissue dilation componentsecured to the shaft of the biopsy component having a plurality ofexpanding elements which have a first contracted configuration to fitabout the elongate shaft of the biopsy device and which have a secondexpanded configuration which expands the passageway within the patient'sbody to facilitate removal of the biopsy device with the attached tissuespecimen from the patient's body through the passageway.
 51. The biopsyassembly of claim 50 wherein at least one of the expanding elements ofthe tissue dilation component is secured to the shaft of the biopsycomponent by a pair of pivoted struts.
 52. The biopsy assembly of claim51 wherein the expanding elements of the tissue dilation component issecured to the shaft of the biopsy component at a location proximal tothe tissue cutting element on the biopsy component.
 53. The biopsyassembly of claim 52 wherein the biopsy component has at least onespecimen securing element to secure the tissue specimen to the shaft ofthe biopsy component during withdrawal from the patient.
 54. A method ofseparating a tissue specimen from a target site within a patient's bodyand removing the tissue specimen through a passageway leading from thetarget site to a location exterior to the patient's body, comprising: a.advancing a biopsy device through the passageway until a distal portionof the biopsy device is located at the target site; b. separating atissue specimen from tissue at the target site by a tissue cuttingelement on the biopsy device; c. securing the separated tissue specimento the distal portion of the biopsy device; d. withdrawing the biopsydevice and tissue specimen secured thereto through the passageway; ande. expanding the passageway around the biopsy device at a locationproximal to the tissue specimen secured to the biopsy device as thebiopsy device is withdrawn to facilitate the withdrawal.
 55. The methodof claim 54 wherein the passageway is expanded by a tissue dilationdevice comprising: a) a first expansion member having an elongatedhandle with an operable distal end, a manually manipulatable proximalend, a tissue expander on the distal end having an exterior configuredto fit into the passageway leading to the target site and a finger gripon the proximal end; b) a second expansion member having an elongatedhandle with an operable distal portion with a distal end, a tissueexpander on the distal end having an exterior surface configured to fitinto the passageway leading to the target site and an interior surfaceconfigured to surround the elongated shaft of the biopsy device, aproximal portion with a manually manipulatable proximal end, and afinger grip on the proximal end; and c) a pivotal connection between thefirst and second expansion members which facilitates adjustment ofspacing between the tissue expanders on the first and second expansionmembers by manipulation of the proximal ends of the first and secondexpansion members.
 56. The method of claim 55 wherein the tissueexpanders on the first and second expansion members of the tissueexpanding device are advanced through a length of the passagewayslidably disposed about the biopsy device disposed therein prior to thewithdrawal thereof.
 57. The method of claim 55 wherein the tissueexpanders on the first and second expansion members of the tissueexpanding device are expanded by contracting the proximal ends of thetissue expanders towards each other.
 58. The method of claim 55 whereinthe tissue expanders on the first and second expansion members of thetissue expanding device are expanded by expanding the proximal ends ofthe tissue expanders away from each other.
 59. The method of claim 54wherein the passageway is expanded by a tissue dilation componentsecured to the shaft of the biopsy component having a plurality ofexpanding elements which have a first contracted configuration to fitabout the elongate shaft of the biopsy device and which have a secondexpanded configuration.
 60. The biopsy assembly of claim 59 wherein atleast one of the expanding elements of the tissue dilation component issecured to the shaft of the biopsy component by a pair of pivotedstruts.
 61. The biopsy assembly of claim 59 wherein the expandingelements of the tissue dilation component is secured to the shaft of thebiopsy component at a location proximal to the tissue cutting element onthe biopsy component.
 62. The biopsy assembly of claim 54 wherein thebiopsy component has at least one specimen securing element to securethe tissue specimen to the shaft of the biopsy component duringwithdrawal from the patient.